Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL).

The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.

The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.

The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atrovastain

    Drug

    atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Non Atrovastatin groupNo intervention 0 interventions
Group B: Atrovastatin groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cardiotoxicity

Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG

Time frame
During the study period along 12 months

Secondary outcomes

1

Cardiotoxicity events correlation to high risk patients

we will correlate cardiotoxicity with the factors that make those patients high risk group for cardiotoxicity

Time frame
along 12 months

Other outcomes

Sponsors and contacts

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